Bacterial Overgrowth, Biofilms, Chronic Rhinosinusitis, Drain Sinus, Endoscopic Sinus Surgery, Rhinosinusitis, Sinusitis
Conditions
Keywords
chronic rhinosinusitis, chronically draining sinus, condemned sinus, post-endoscopic sinus surgery
Brief summary
The purpose of this investigation is to conduct a randomized controlled trial within a subgroup of difficult-to-treat patients with CRS, evaluating the use of topical xylitol treatment concurrently with topical steroid/antibiotics combination in the effort to disrupt biofilms and improve disease control. The effectiveness of topical surfactants is a research gap in treating CRS but has promising correlates in other medical fields. Specifically, the investigators will be studying the effect of topical xylitol therapy on biofilm production with the use of PCR bacterial sequencing before and after medical intervention.
Detailed description
Problem Statement: The purpose of this investigation is to conduct a trial within a subgroup of difficult-to-treat patients with CRS. This difficult group of patients will have undergone an exhaustive surgical and medical treatment of CRS These patient often will be frustrated with the lack of improvement in their symptoms despite maximal medical and surgical therapy. The effectiveness of topical surfactants is a research gap in treating CRS but has promising correlates in other medical fields. Purpose of Study/Potential Impact: The purpose of this investigation is to conduct a randomized controlled trial within a subgroup of difficult-to-treat patients with CRS, evaluating the use of topical xylitol treatment concurrently with topical steroid/antibiotics combination in the effort to disrupt biofilms and improve disease control. The effectiveness of topical surfactants is a research gap in treating CRS but has promising correlates in other medical fields. Potential Benefits: Topical xylitol could potentially decrease CRS symptoms, leading to improvements in patient quality of life. This decrease could potentially lead to fewer visits to primary care physicians/otolaryngologists. These could lead to less antibiotics, radiographs being obtained and unnecessary surgical procedures being performed, all of which could potentially reduce the burden of medical expenditure in the treatment of this disease. Potential Risks: Potential risks are minimal but include a sweet aftertaste in the mouth and burning in the nose; which have been reported in previous studies. Hypothesis: 5% (wt/vol) Xylitol saline irrigation into the diseased paranasal sinus, as a part of a post-ESS refractory CRS management plan, will reduce biofilm formation in the sinus and result in symptomatic relief in affected patients. General Design: A prospective, randomized, double-blinded experimental design will be utilized. Patients will be randomized into the xylitol-saline treatment arm versus the control saline arm. Concurrent corticosteroid/antibiotic therapy will be utilized in both arms based on results of bacterial DNA sequencing. Patients will undergo weekly in-office irrigations for three weeks and will be evaluated one month and three months post-treatment. The postoperative care will be standardized across all participants.
Interventions
DRUGXylitol
Topical 5% Xylitol (wt/vol) diluted in saline nasal irrigant. Topical corticosteroid and antibiotic as directed by bacterial DNA sequencing results will be diluted in this irrigant and administered concurrently.
DRUGSaline
Saline as a standard-of-care nasal irrigant. Topical corticosteroid and antibiotic as directed by bacterial DNA sequencing results will be diluted in this irrigant and administered concurrently.
Sponsors
Tulane University School of Medicine
Ochsner Health System
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Adult patients above the age of 18 * History of chronic rhinosinusitis history who had undergone bilateral endoscopic sinus surgery to include at a minimum maxillary antrostomy and anterior ethmoidectomy. * Continued chronic sinusitis that is refractory to medical therapy after surgical intervention
Exclusion criteria
* Patients under age of 18 * Non-English speaking * History of immunodeficiency disease * Cystic fibrosis * Primary ciliary dyskinesia * History of granulomatous disease * Active smoker * Treatment with antifungal medications * Use of antifungal medications * Acute bacterial infection requiring antibiotics * Active pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The effect of topical xylitol therapy on biofilm production with the use of PCR bacterial sequencing before and after medical intervention. | 3 months | Bacterial DNA sequencing obtained via endoscopic swab will be performed pre-treatment to analyse the presence of biofims in the diseased sinus. This assay will be repeated from the same sinus post-treatment with 5% Xylitol (wt/vol) to evaluate if medical intervention decreases biofilm production in the diseased sinus. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sino-Nasal Outcome Test-22 (SNOT-22) | 3 months | Maximum score of 110 points based on responses to 22 questions |
| Brief Smell Identification Test (BSIT) | 3 months | Total scores range from 0 to 12; higher scores indicate greater olfactory function |
| Endoscopic appearance of the patient's sinuses in response to the use of topical xylitol | 3 months | — |
| Correlation of DNA seqeuncing results with conventional sinonasal cultures | 3 months | — |
Countries
United States
Outcome results
None listed